Non-contact damage-free ultrasonic cleaning of implanted or natural structures having moving parts and located in a living body

ABSTRACT

Ultrasonic, sonic or vibratory energy, delivered non-invasively, minimally invasively or invasively (e.g. surgically), is utilized to provide direct cleaning action at or to the location of the implanted device such as a prosthetic heart valve with undesirable deposits of at least some amount thereon or therein. Such ultra-sound energy may be aided by the use of a drug in association or cooperation with the acoustic irradiation. The “cleaning” acoustic energy may optionally be delivered under the guidance of an imaging modality and may be delivered in a timed or gated manner such that the valve occluders or leaflets are in a preferred position (assuming they are functioning) during exposures.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority from provisionalapplication Ser. No. 60/463,918, filed Apr. 17, 2003.

TECHNICAL FIELD

[0002] The present application is directed generally to prosthetic heartvalves, and, more particularly, to cleaning such heart valves,preferably in situ, with acoustic energy.

BACKGROUND ART

[0003] Background Discussion.

[0004] Prosthetic heart valves are probably one of the most well-knownimplanted medical devices and are installed in an ailing human heart forthe purpose of correcting cardiac valvular dysfunctions of varioustypes. Such valves are made either of artificial biocompatibleengineering materials, such as pyrolytic carbon, titanium, and silicone,or are fashioned out of donor tissues or actual valves or other tissuessourced from pigs, cattle or human donors.

[0005] Particularly for cardiac valves made of such artificialengineering materials, experience has shown that over time, even withthe administration of anti-clotting, anti-coagulant or anti-plateletdrug treatments, that undesirable buildups of clot, fat, calcium orother undesirable cellular or debris deposits can grow on various valvesurfaces and valve pivoting-joints, thereby interfering with valveoperation. In extreme cases, the moving occluder portions of such valvescan become physically stuck, so the valve is frozen in a random openposition. In less severe cases, deposits interfere with the properseating of the moving occluders, thereby causing leaks and flowirregularities, such as turbulent jets. Such flow affects can encouragemore such deposits and/or damage to the blood itself. They also causefunctional cardiac problems. Furthermore, such deposits may achieve afinite size, then detach from the valve and cause a downstream clot orstroke elsewhere.

[0006] It is also known that even for prosthetic heart valves made fromanimal or human tissues, that children, in particular, exhibit excessivecalcium deposits on such tissue-based valves due to children's uniquebody processes supporting their growth and maturation. It is also knownthat calcium deposits may take place inside of valve and other movingtissues, eventually contributing to their stiffening, tearing orstenosis. Expressly included in the scope herein are such buried,interior or interfacial deposits that can possibly cause valve leafletsto fuse together, tear or lose required elasticity.

[0007] A general answer to many of these problems, particularly theclotting-based problems, has been to administer a variety ofanti-clotting, anticoagulant or anti-platelet drugs. Suchclotting-factor inhibiting drugs include warfarin (Coumadin®). Suchthrombin inhibitors include heparin or lepirudin (Refludan®). Suchanti-platelet drugs include aspirin, ticlopidine (Ticlid®), clopidogrel(Plavix®), tirofiban (Aggrastat®) and eptifibatide (Integrilin®). Someof these medications are administered for years after the implantsurgery, if not permanently thereafter. In general, there are someundesirable side-effects to taking many of these drugs, the mostimportant of which are that (a) one's propensity to bleed is enhanced,and (b) in some situations, bleeding can be initiated, particularly inthe brain, by such drugs, even without a provoking injury. Thus, majoreffort has gone into getting the exact bodily concentration of suchdrugs correct on an ongoing basis. If properly practiced, such drugadministration greatly reduces valve deposits, particularly of theclotting type, but does not eliminate such deposits completely. Anotheranswer to these problems has been the avoidance of using engineeredmaterial valves in children in favor of bioprosthetic valves made ofreal tissues. Again, this helps greatly but does not totally eliminatedeposition problems.

[0008] What would be highly desirable is a device or method for cleaningsuch deposits, preferably in a damage-free non-contact manner, at leastfrom cardiac implants such as prosthetic valves, in cases wherein thedrugs mentioned above have not worked sufficiently to avoid suchdepositions or could not be used for medical reasons. It would furtherbe attractive if such a device or method could allow for a reduction oreven elimination of the use of such anti-clotting (or thrombolyticclot-dissolving) drugs and their undesirable side-effects and lifestylelimitations. For example, using such a device or method, one could avoidthe drugs altogether or could take a patient off such drugs for aprolonged period to allow for an unrelated surgery and avoidance ofmassive bleeding related to that unrelated surgery. So, the presentinventors foresee the use of the inventive device and method at leastonce if not several times on a given patient. Ideally, the device andmethod can be practiced in noninvasive, semi-invasive, and invasivesituations, thus allowing its use in routine maintenance as well asduring surgery. Such use could be after cardiac function has beenimpacted or might be on a maintenance basis before such function isimpacted. In all cases, at least some existing deposit would be removedor rendered removable by the body or with the help of an administereddrug.

[0009] Of particular use would be a device or method which can do so forthe moving parts of devices such as heart valve leaflets and canlikewise clean other nonmoving parts of actuating implants which wouldbe easily damaged if directly contacted, the damage inviting furtherdeposits. Cleaning the nonmoving parts of such actuating (having movingparts) implants means doing so in the presence of a nearby moving part.Thus, an additional object of the invention is the provision of anon-contact or gentle-contact cleaning method that can clean suchimplant parts without damaging the moving parts and without damaging thecleaning device itself.

[0010] It will be noted from the title that the present inventorsinclude certain deposits on natural body structures also within thescope of the present invention. In particular, the present inventors arenot familiar with any art which involves the acoustic removal ofundesirable depositions on natural valves, whether they be in the heartor in the lumens such as in the venous or lymphatic system of the legs,for example. There is much art, however, regarding acoustically cleaninglumens that have no moving parts in the sense that valves have moving orswinging occluders or leaflets. Thus, the present invention is directedto the cleaning of valves and body members that are supposed to havemoving parts, natural or otherwise.

[0011] The bulk of the discussion below will focus onimplanted-structure cleaning as depositions are, or at least have thepotential to be, more prevalent upon or within them.

[0012] The present disclosure also teaches methods and devices toacoustically assess the extent of such deposits-particularly onartificial engineered valves made of engineering materials. Theseacoustic or ultrasonic-assessment aspects may or may not be usedtogether with the invention's therapeutic aspects.

[0013] Prior Art.

[0014] The present inventors have found no art relating directly to theuse of ultrasound to clean implanted actuating prosthetic devices ofundesirable existing deposits or overgrowths in a non-contact mannerwhile thereby causing no damage, scratching, abrasion or permanentdeformation to the implant itself. It should be noted that ifcontacting-cleaning means were used (such as abrasive devices), thenthey will cause implant surface-damage or scratching, which will surelyinvite further such deposits. As mentioned earlier, the presentinventors also have not found any teaching regarding acousticallycleaning natural valves normally having natural actuation motions in thecardiac, lymphatic or arterial systems.

[0015] Pharmasonics, Inc. has focused several patents on treatingvascular tissues prone to hyperplasia or restenosis after a vascularprocedure is performed. These patents are directed to preventativeprocedures and do not deal with deposits that have already taken placenor with deposits on or in actuatable implants or body members. In somecases, there is a lumen stent put in place, which is at leastcontributing to the restenosis process that they attempt to treat withtheir inventive therapy. In all cases, their approaches primarilyinvolve treating the distressed tissues adjacent the stent such thatthose tissues do not overgrow the stent interior diameter, causingflow-blockage. There are no actuating or moving parts whose actuationwould be interfered with by the deposits. Our definition of a moving oractuating member covers any implant, natural member or organ wherein anysolid or semisolid material (like tissue or metal, for instance) isexpected to actuate at least once. Thus, venous, lymphatic and cardiacvalves of natural and implanted types are covered. We include in ourscope actuation being the one-time or occasional alteration,maintenance, adjustment or servicing of an implant that may be fouled bysuch deposits. A perfect example of this is, for example, a pacemakerlead that has been fouled by tissue or deposit overgrowth such that itneeds to be cleaned so that it can function properly or be exchanged fora new one. There the actuation is a one-time plugging-in (and out) of anelectrical lead connector. Two last examples of actuation are the normalcyclic motion of various bodily organs due to perfusion (e.g., heart,kidney, liver) and the actuation of muscles and tendons. In both ofthose cases, known deposits can interfere with the normal distension orextension of such members and would benefit from the therapy of thisinvention.

[0016] U.S. Pat. No. 6,361,554 to Brisken (and assigned to Pharmasonics)and U.S. Pat. No. 6,387,116 to McKenzie (and assigned to Pharmasonics)are the nearest to being relevant to the discussion here and will bediscussed below. However, neither patent alone nor in combination withthe other, leads one to the present invention herein. Other patentsreviewed but not considered at all relevant include U.S. Pat. Nos.5,725,494; 5,728,062; 5,931,805; 6,210,393; 6,221,038; 6,228,046;6,494,874; and 6,503,243, all to Brisken (and assigned to Pharmasonics).

[0017] U.S. Pat. No. 6,361,554 to Brisken (the '554 patent) is entitled“Methods and Apparatus for the Subcutaneous Delivery of AcousticVibrations”. What this patent teaches is a preventative therapy to avoidundesired stent depositions, not the removal of prior depositions northe removal of depositions interfering with or potentially interferingwith the actuation or distension of an implant or body member. Briskenutilizes the sonically-driven stent resonation to indirectly treat thetissue adjacent the stent and prevent it from later forming overgrowthsonto or into the stent. More specifically, he teaches that acousticexcitations are delivered from outside the body, that the stent issmaller than his illuminating beamwidth, and that the stent isspecifically pre-designed or modified to have a characteristic resonantfrequency. Furthermore, the characteristic pre-chosen resonant frequencyis utilized in a manner such that the resonant stent causes acousticenergy to be preferentially redeposited at the diseased interfacesbetween the stent and the adjacent tissues by his process ofre-radiation in the form of reradiated (from the driven stent)vibrations or heat. Note that multiple treatments are suggested and thatusing a semi-invasive catheter for such treatments is taught to beavoided. The reader will appreciate that a stent, once placed, is anonactuating device not subject to brittle fracture. The beamwidth beingso much larger than the stent allows for easy aiming. Recommendedimplants for the preventative therapy delivered by the '554 patent focuson vascular stents, grafts and valves widely familiar to the vascularsurgeon. Note that because the '554 patent utilizes externally appliedultrasound, that ultrasound cannot directly illuminate the stent orimplant interior, thus the need for an indirect approach. So directtreatment of deposits is not taught-only indirect treatment-and onlynoninvasive indirect treatment. By direct treatment we mean that theultrasound energy performs its function directly on a deposit. The aboveprior art performs only noninvasive indirect therapy wherein existingdeposits are not directly targeted, and furthermore are taught to beavoided by advance use of that invention before such deposits exist.

[0018] Contrary to the '554 patent, the invention herein has severalfundamental differences including the following: (1) deposit materialsthat have already deposited or formed are themselves treated, (2) thedeposits are primarily treated directly, not indirectly, (3)re-radiation is not primarily depended upon to provide an indirectlydelivered or preferentially focused therapy, (4) the implant is notrequired to be modified in design to achieve a particular resonance, (5)it is recognized that any resonant property of the implant, if present,will vary as a function of the deposit burden attached thereto, (6) theacoustic signature of a clean implant is optionally utilized to deducethe presence and extent of such deposits and the progress of theirremoval, (7) it is recognized that any deformable implant (such as astent) will have its native resonant frequency(s) modified by the exactamount of deformation and by the loading by adjacent tissues, and (8) itis recognized that some implants are subject to brittle fracture and canbe broken by such driven resonances, particularly implants made ofceramics or glasses which are not acoustically lossy and are brittle.Furthermore, the '554 patent does not teach what acoustics arereradiated, i.e., whether they are harmonics of the driving frequency orare solely the primary driving frequency. The present inventorsspecifically discuss the management of such harmonics if they areallowed to be present.

[0019] U.S. Pat. No. 6,387,116 to McKenzie (the '116 patent) entitled“Methods and Kits for the Inhibition of Hyperplasia in Vascular Fistulasand Grafts” is somewhat similar to the above, except that it typicallyinvolves only natural tissue structures therein whose potentialhyperplasia is to be avoided. Note that there is no mention of anyresonant attribute of an artificial implant, stent or graft nor anymention of using the acoustics themselves to clean up prior deposits.New elements relative to the '554 patent are the use of a drug ifdesired, the avoidance of cavitation, and the avoidance of temperaturerises of more than 2 degrees Centigrade. Since there is virtually nodiscussion of any implant's acoustic properties nor the cleaning ofprior deposits on any implant, this patent is thus, after inspection,regarded as irrelevant. It is also preventative in nature like the '554patent.

[0020] Thus, there remains a need for a mechanism for removingundesirable deposits from an implanted device, such as a prostheticheart valve, having at least one moving or movable part. This need alsoextends to such deposits in or on a natural bodily member or organhaving a naturally moving, distending or actuating part or portion. Theneed also extends to one-time actuation required to maintain or serviceexisting implants, the actuation being a required movement of at least aportion of the implant or its connection means. Thus, the replacement ofa fouled pacemaker lead is included within the scope of the presentinvention because the lead and its connector must be moved (removed andexchanged) relative to the pacemaker body itself.

DISCLOSURE OF INVENTION

[0021] In accordance with the present invention, ultrasonic, sonic orvibratory energy, delivered non-invasively, minimally invasively orinvasively (e.g., surgically), is utilized to preferably provide directcleaning action at or to the location of an implanted artificial orbioprosthetic device, such as a prosthetic heart valve, or a naturalbodily member or organ with a naturally moving, actuating or distendingpart or portion with undesirable deposits of at least some amountthereon or therein. Such ultrasound energy may be aided by the use of adrug in association or cooperation with the acoustic irradiation. If adrug is used, the ultrasound may enhance the performance of that drugvia its acoustic and/or thermal attributes. Alternatively, or inaddition, the drug may make it easier to achieve deposit removal bydestabilizing or softening such deposits. Such a drug might be given atleast one of before, during or after the acoustic therapy.

[0022] Specifically in accordance with the present invention, apparatusis provided that is capable of the non-contact or damage-free removal orerosion of undesirable deposits situated: (a) on or in an implantedartificial or bioprosthetic device having at least one moving ormovable, actuatable or distendable part or portion (“moving or movable”hereinafter), or (b) on or in a natural bodily member or organ having anaturally moving or movable part or portion. The deposits to be removedor eroded interfere or potentially interfere with at least one of (a)any designed function of the implanted device, (b) any natural functionof the natural bodily member or organ, or (c) any circulatory systemprocess necessary for normal healthy living. The apparatus comprises:

[0023] an acoustic emitter capable of emitting acoustic energy;

[0024] a means for exciting the acoustic emitter to emit acousticenergy;

[0025] a means for acoustically coupling the acoustic energy into thedeposits directly or indirectly;

[0026] a means for operating the emitter(s) to at least partially removeor otherwise erode the deposits; and

[0027] optionally, an administered drug to aid the removal or erosionprocess, to prevent or slow further such deposits, or to treat aside-effect of treatment with the emitter.

[0028] Further in accordance with the present invention, an acousticmethod capable of the non-contact removal or erosion of such undesirabledeposits is provided. The method comprises:

[0029] providing the acoustic emitter;

[0030] exciting the acoustic emitter to emit the acoustic energy;

[0031] acoustically coupling the energy into the deposits, directly orindirectly, to at least partially remove or otherwise erode thedeposits;

[0032] either passing the at least partially removed deposits orotherwise eroded deposits into the body or physically removing the atleast partially removed deposits or otherwise eroded deposits by acollection, trapping or immobilization means; and

[0033] optionally administering a drug to aid the removal orimmobilization.

[0034] Still further in accordance with the present invention, a methodis provided for assessing the state of fouling by undesirable depositsof an implant or of a natural valve in a living body, the implant orvalve having at least one moving or movable part. The method comprises:

[0035] obtaining, in any manner, an acoustic signature of the operationof the implant or valve at least under unfouled conditions inside oroutside a living body;

[0036] obtaining, in any manner, using passive reception or pulse-echoactive probing, an acoustic signature of the implant or valve thought topossibly have fouling thereon or therein;

[0037] the possibly-fouled signature containing at least one of: (1)naturally generated acoustic features known to be caused by fouling, and(2) artificially excited features known to be excited upon the presenceof fouling;

[0038] comparing the fingerprints looking for fouling features that havenewly been incorporated into the signature; and

[0039] concluding that newly added features which match known foulingfeatures indicate fouling.

[0040] The “cleaning” acoustic energy may optionally be delivered underthe coordinated or real-time guidance of an imaging modality and may bedelivered in a timed or gated manner such that the valve occluders orleaflets are in a preferred position (assuming they are functioning)during exposures. For example, if the cleaning ultrasound is deliveredvia a catheter, then it might be delivered to a valve from inside oroutside the heart. If it is delivered via a transesophageal transducer,then it would be delivered from the esophagus. If it is deliveredsurgically, then it might be delivered upon a surface of the exposedbeating heart or onto a lumen connecting to the valve in question. Acombined ultrasound imaging probe and ultrasonic cleaning probecontaining one or more transducers could be employed, for example. It isto be emphasized that the invention may or may not involve bodilyresonating the implant, or a portion thereof, itself, and in all casesat least some direct cleaning action is delivered which does not requiresuch implant resonating; the deposit is directly bathed in emissions andis itself broken down or acted upon directly. The implant might be anartificial prosthetic heart valve or a combination valve/stent in avenous lumen, for example. In all cases, a pre-existing deposit isoperated upon. The scope of the invention includes any implantedartificial or bioprosthetic device, natural bodily member or organhaving a moving or movable part or portion that is subject toundesirable depositions on or in it, which could, or do, negativelyimpact the patient directly or indirectly. This would include thecleaning or dissolution of depositions, which would only harm thepatient if they were to break free and passage into the bloodstream.Thus, it would include removing deposits from the nonmoving parts ofheart valves as well, such a heart valve requiring a non-contactdamage-free method of cleaning of any or all of its parts.

[0041] The present inventors further teach, particularly for fragilenon-deformable implants such as engineered artificial heart valves, thatone may utilize acoustic spectral characteristics of clean vs. dirtyimplants to deduce something about the extent of such deposits or theextent of their removal. The avoidance of delivering acoustic energiesthat could fracture such brittle implants is also taught.

[0042] Finally, the present inventors teach that the cleaning acousticsmay be directed at a portion of the implant, member or organ such thatthe acoustic intensity is maximized at desired locations or such thatother fragile portions of the implant are avoided by the cleaningprocesses.

BRIEF DESCRIPTION OF THE DRAWINGS

[0043]FIG. 1, the sole Figure, schematically depicts a (non-tissue)prosthetic heart valve mounted in a patient's heart, the valve havingundesirable deposits thereon and therein, wherein ultrasound waves areshown directed toward the deposits from an invasive (in this example)therapy transducer of the present invention.

BEST MODES FOR CARRYING OUT THE INVENTION

[0044] Moving directly now to the Figure, there is shown (not to scale)an artificial prosthetic heart valve 2 mounted in cardiac tissue 1defining a chamber of the heart. In fact, item 2 is the known typicalannular valve body of such a valve. Typically, body 2 is made ofpyrolytic carbon or titanium. Typically, the valve 2 will have one ormore swinging leaflets or occluders 3A and 3B as shown. Note that in theFigure, normal blood flow F is upwards in the direction of flow arrow12. Valve 2 acts as a check valve preventing downwards flow by closingits leaflets 3A and 3B to the respective closed and seated phantompositions 3C and 3D. The leaflets swing as indicated by arrows 13. Alsotypically, leaflets 3A and 3B will swing upon hinged pivots of the type3E and 3F. The axis of such pivoting is normal to the plane of thedrawing. Typically, valves will have a fabric covering 4, which allowsthe use of sutures 5 to attach the valve 2 to the cardiac tissue orannulus 1. Blood 6 is shown as being present on both sides of the valve2, with its desired flow 12 upwards for the sake of illustration.Finally, as is known in the art of valve construction, the movingleaflets 3A and 3B seat themselves in their phantom closed positions 3Cand 3D upon a sealing valve seat seen in section as rim 3G and 3H.

[0045] While the majority of the description herein is directed toimplanted artificial or bioprosthetic devices having at least one movingor movable part or portion, it will be readily appreciated by thoseskilled in this art that the same teachings may be applied to a naturalbodily member or organ having a naturally moving or movable part orportion. In all cases, the deposits either interfere or potentiallyinterfere with at least one of (a) any designed function (or anyrequired maintenance) of the implanted device, (b) any natural functionof the natural bodily member or organ, or (c) any circulatory systemprocess necessary for normal healthy living.

[0046] The valve 2 thus may be an artificial, bioprosthetic, or naturalvalve, located anywhere in the body and having at least one moving part,referred to herein as a leaflet or an occluder 3A, 3B. The valve 2 maybe of any type supportive of a patient's cardiac, lymphatic or arterialsystems. The leaflet or occluder 3A, 3B, if the valve 2 is artificial orbioprosthetic, may comprise a biocompatible engineering material such aspyrolytic carbon. Such biocompatible engineering materials arewell-known. Alternatively, the leaflet or occluder 3A, 3B may comprise atissue material of any type, whether natural or bioprosthetic. Thetissue may be, at least in part, donor human tissue, donor animaltissue, lab-grown tissue or artificial tissue.

[0047] The leaflet or occluder 3A, 3B may be a part of the patient's ownnatural valve, anywhere in the body. Examples of such natural valvesinclude cardiac valves, venous valves, and lymphatic valves. Weemphasize occluders as they are commonly fouled but we include in thescope any other connecting tissues or muscles which, if fouled bydeposits, will cause a functional valve problem.

[0048] Referring back to FIG. 1, it will be noted that there areundesirable deposits 11A, 11B, 11C upon the valve in various places.Deposits 11A are on the leaflets themselves. Deposit 11 B is inside theannulus 2. Deposit 11 C is in the dangerously nearby region of the valveseat 3G, 3H. Those skilled in the art of valves and valve deposits knowthat such deposits can also take place in numerous other positions orinside/outside surfaces (not shown), including within the pivot or hingeregion(s) 3E, 3F, on the leaflet edges, or directly on the valve-seatsealing surfaces etc. It is not the point here to teach such details ofhistorical deposit distributions.

[0049] At least some of the deposits are on or in at least one of themoving, movable or nonmoving parts of the implant, member or organ andpresents a potential or existing problem. For example, the deposits maybe on the leaflet or occluder, which moves, or on the seating or sealingedge or face against which the leaflet or occluder seals. Or, at leastsome of the deposits may interfere with the proper moving of a movingpart of the implant or interfere with a moving part or medical devicearranged or designed to be passed through, passed into, mated to orthreaded into the implant, such as a hinge, pivot or flexural area ofthe valve.

[0050] The presence of the deposits may likely ease or encourage theformation of additional deposits as is known from clinical experience.The deposits may interfere with the designed or natural function of theimplant, member or organ, thereby interfering in the desiredhydrodynamic operation of a natural or implanted valve supporting theheart, the lymphatic system or the arterial system. Thus, the depositsmay interfere with normal blood flow trajectories, normal hemodynamicsor normal cardiac capacity. The removal of deposits as taught herein mayprevent a potential stroke or any cardiac dysfunction or degradedfunction.

[0051] Specifically included in the scope of “deposits” is pannus, whichis an occasional lateral tissue overgrowth (not shown) onto the valvesurface or valve throat. Although pannus is technically not a deposit,it is still a cleanable (or killable) tissue material that interfereswith valve operation. Also included in the scope of “deposits” are bloodconstituents, whether clotted or not, calcium, fatty deposits, bodilyorganic debris, and bacteria. Specific examples of such depositsinclude, but are not limited to, at least one of (a) surface-deposited,calcium-containing material, (b) calcium-based deposits inside tissuesor in tissue interfaces, (c) calcium-based deposits inside implantmaterials or in an interface including at least one implant material,(d) fatty deposits on surfaces or inside tissues or engineeringmaterials, (e) organic debris on surfaces or inside tissues orengineering materials, (f) plaque-like deposits, and (g) any depositwhich contributes to stenosis or a loss of elasticity of a moving ormovable tissue or implant component.

[0052] It will be noted that the valve 2 is depicted oversize in sectionwithin a patient's body having a skin surface 14. Outside the skinsurface 14, there is the possibility of applying a noninvasive acoustictreatment and/or an invasive treatment can be applied from inside thebody. Details of the heart are not shown in the Figure, as they are notnecessary to understand the invention. Given the choice betweennoninvasive (no incisions), semi-invasive (small incisions), minimallyinvasive (tiny localized incisions or punctures) and invasive (largeincisions) acoustic energy delivery, any one of the heart valves can beacoustically illuminated from at least one direction or angle to achievethe inventors' purpose here. We emphasize here that the therapy of theinvention, if invasive to any degree, may be done along with othersurgery already being done and thus our therapy is not the root cause ofan invasive procedure. This makes the invention a concomitant procedurein those cases. Such situations are a common surgical occurrence and arequite common in heart surgery, for example.

[0053] By way of invasive or semi-invasive energy delivery, a catheteror other ultrasound probe 7 is shown, directed toward the valve 2 inFIG. 1. Such a probe could be delivered, for example, through thefemoral artery, carotid artery or through a laparoscope through thechest. Acoustic device 7 is shown as having an acoustic emitter 8 and anacoustic matching layer 9. Acoustic cleaning waves 10 are shown directedtoward the valve 2 for purposes of cleaning or removing deposits of thetype 11A, 11B, 11C or pannus (not shown). Those familiar with theacoustic art know that piezoelectric, ferroelectric, electrostrictive,magnetostrictive, or thermoacoustic transducers can be fabricated todeliver directed acoustics in the manner shown. Optoacoustic orlaser-based acoustics-producing catheters may also be employed.

[0054] As an example, transducer 8, 9 could be a piezoceramic (PZT orlead-zirconate-titanate) transducer operating at 1 megahertz insingle-pulse, multipulse or continuous wave fashion.

[0055] The acoustic emitter 7, as an alternative option, may betemporarily or permanently integrated into the patient's body or intothe implant itself, and may be automatically operated without constantpatient or doctor manipulation. Alternatively, the acoustic emitter 7may be integrated or co-mounted with an imaging device, such as anultrasound transducer, an infrared camera or an imaging scope of anytype used during therapy. Thus, an independent imaging device may beemployed, such as to guide or plan a treatment. Examples of suchindependent imaging devices include, but are not limited to, ultrasoundimaging, fluoroscopy, MRI (Magnetic Resonance Imaging), CAT (ComputedAxial Tomography) scan, PET (Positron Emission Tomography) or videoscopewith a waterpath.

[0056] The transducer 8, 9, in the invasive case shown, might be movedin close proximity to the valve 2 (as shown) such that the deliveredacoustics are mainly directed to areas of the valve needing cleaning.Thus, the transducer might be focused or unfocused, depending on theworking distance desired. Focusing would likely be done for smallworking distances, which allow for minimal (total) acoustic power to beused to get the job done. The present inventors anticipate the use ofprotective devices (not shown) such that the cleaning transducer is notmechanically caught up in the moving leaflets 3A, 3B. Thus, the implant,member or organ may be at least temporarily immobilized; suchimmobilization may be done by the juxtaposition or insertion of a softor compliant protective member than mechanically blocks the motion, suchas an inflatable balloon or other pressurized member, inflated by atleast one of a liquid or a gas. As an example, one could envelope theprobe 7 tip in a saline filled balloon (not shown) such that if theballoon did hit a moving leaflet, there would be no mechanical damage tothe valve by the transducer nor any damage to the transducer. It shouldbe emphasized that preferably a non-contact scheme is employed, at leastin the sense that no portions of the therapy device 7 which couldinterfere with or damage the implant surfaces come in contact with suchsurfaces. Recall that even minor surface scratches invite moredeposition activity. Thus, either no portion of the emitter means 8, 9contacts the implant, member or organ or any portion of the emittermeans 8, 9 that does contact the implant, member or organ comprises acompliant or deformable protection-affording material.

[0057] Outside the patient's body 14 is shown alternative acousticdelivery of therapy waves 10A. This is to emphasize that the acousticenergy may be delivered from anywhere on (coupled-to in any manner) orin the body in any noninvasive, minimally-invasive or invasive manner.The delivery location will probably be determined at least in part bywhether the therapy is of a scheduled maintenance sort or is beingdelivered together with a related or unrelated surgery, possibly to fixserious functional problems.

[0058] Acoustic, sonic or vibratory energy 10 or 10A preferably actsdirectly upon deposits 11A, 11B, 11C that are typically enveloped bysurrounding blood 6 (or other liquid or tissue path between the emitterand the deposits) capable of transmitting such acoustics directly intothe deposits. In this manner, it is not necessary to pre-design theimplant such that it can be resonated at a particular frequency. Theacoustic energy may act upon at least a portion of the deposits,possibly in cooperation with one or more drugs, to break-up, break-down,dissolve, de-amalgamate, erode or otherwise attack the deposits. Forexample, the acoustic energy may aid in the permeation of the depositsby such drug(s) or by a natural anti-clotting blood constituent or both.Such action may or may not include significant cavitation, streaming,erosion or dissolution phenomena in the region of the deposits,depending on the fragility of the implant. Cavitation and streaming willfurther accelerate these removal/erosive processes. The inventivetherapy allows for heating of the deposits using the ultrasoundexposure, if that accelerated deposition breakdown (e.g., for fattylayers). It will be noted that many valve parts, such as pyrolyticleaflet occluders, can be safely heated without damage-particularly byhigher frequencies (e.g., 7 to 12 MHz) that will not cause resonantdamage to the valve itself. In this manner, heating of several tens ofdegrees Centigrade or more is allowable, and can be thermally quenchedquickly by the blood flow. Within the ambit of the present invention isthe use of blood additives such as contrast microbubbles to providecavitation nucleation sites. Such microbubbles would ideally be burstand cavitated only in the direct neighborhood of (or within) thedeposits to be removed. Thus cavitation may optionally be aided by thepresence of cavitation nuclei or facilitators, such as contrastmicrobubbles, gas bubbles or surfactants.

[0059] The acoustic energy may be coupled into the implant, member ororgan by, for example, (a) coupling to a patient's external skin, (b)coupling from within a patient's natural body passage or space, (c)coupling into the surface of a surgically exposed or accessed organ ortissue surface, (d) coupling from a natural body lumen into an organ orimplant, or (e) coupling into a cardiac structure or implant from withina cardiac chamber.

[0060] Frequencies of acoustic excitation may be in the range of 1 Hz to100 MHz, preferably in the range of 1 KHz to 10 MHz, and most preferablyin the range of 5 KHz to 10 MHz. Acoustic powers may be in the range ofmilliwatts per square centimeter to kilowatts per square centimeter,preferably in the range of 0.5 watts/cm² to 5000 watts/cm², and mostpreferably in the range of 5 to 500 watts/cm². The particular acousticenergy selected is chosen for its ability to remove the deposits upondirect radiation by the acoustic energy. The determination of theconditions for such removal is not considered to constitute undueexperimentation.

[0061] The acoustics may be focused, collimated, weakly focused, orunfocused. Preferably, they will be at least collimated if not somewhatfocused to achieve a higher useful power density in the treatment field.The transducer or emitter, if focused, may be mechanically focusedand/or electronically focused, beam-formed or steered as by use of amultielement array technology, which is widely known. Preferably, theuseful treatment portion of the beam will be large enough such thatprecision unaided mechanical scanning of the implant is not required. Asan example, a treatment catheter could have a 7 mm diameter with a 7 mmdiameter spherically-focused transducer at the tip. The transducer couldbe weakly focused inwards to a point, for example, at 25 mm distance. Inthis manner, the transducer can paint large swaths of the implant if itis held at a distance in the range of 5 to 15 mm, for example. Thepatient may receive one or more treatments or multiple scheduledtreatments.

[0062] Included within the ambit of the present invention is thechoosing of a frequency such that one of these four conditions is met:(a) a frequency employed has a characteristic wavelength on the order ofa characteristic dimension of a typical deposit or deposit constituent,thus improving coupling into the deposit, (b) a frequency employed ischosen because it is known to be capable of exciting a resonance orresonance harmonic in an implant portion, (c) a frequency employed isknown not to excite a resonance or resonance harmonic in an implantportion, or (d) broadband frequency or scanned frequency is employed inorder to gain the benefits of more than a single frequency. The resonantexcitation may contribute to indirect delivery of acoustic energy intothe deposits and the energy may contribute to the removal or erosion ofthe deposits. Indirect energy may be deposited upon or into the depositsby first coupling the acoustic emissions into the implant, member ororgan and then the acoustic energy in turn being delivered to thedeposit(s). Many applications of the invention will involve. usingfrequencies that directly attack deposits but fail to excite implantresonances. Typically, this means frequencies which are chosen to not beequal to a harmonic or base-frequency of an implantresonance-particularly one of the lower harmonics whose amplitude wouldbe expected to be larger than that of a higher harmonic. So, forexample, if the implanted valve had a resonant frequency at 100 KHz andit is desired to have only direct deposit attack and no resonantexcitement we would choose not to utilize a frequency f, at least notfor any significant pulse-length, having a value of, for example, ½ f,1f, 2f, 3f, etc. or 50 KHz, 100 KHz, 200 KHz, 300 KHz etc. Thus, wecould likely utilize 1 MHz, for example.

[0063] In general, the less intervening tissue that is situated betweenthe therapy transducer and the implant to be cleaned, the higher thefrequency can be because intervening tissue losses are not the limitingfactor. Thus, in the Figure, emissions 10 could be in the few megahertzand above range, while emissions 10A would preferably be somewhat lowerin frequency, e.g., a few megahertz or lower.

[0064] In general, one does not want to deliver excessive high poweracoustic waves to an artificial implant that has brittle components withresonant frequencies that could be excited by the therapy transducer. Itmight indeed be possible to deliver enough grossly excessive acousticpower to break pyrolytic carbon leaflets 3A and 3B if that delivery wereat a resonant frequency of the leaflet. Thus, it is preferred that theprimary mechanism of deposition attack is direct, which does not requirethe implant itself be maximally and efficiently resonated and merelyrequires that acoustic energy can arrive at a deposition through blood,through tissue, or through the implant in the form of non-resonantexcitations. Also included in the ambit of the present invention isresonance of at least a portion of the implant at an amplitude known tobe safe from prior engineering characterization. Such driven resonanceor non-resonant vibrations add the indirect deposition attack modebecause the deposition is essentially being shaken on a driven movingfoundation (the implant). We note specifically that even for anartificial valve having a resonance of its leaflet, say at 100 KHz, thatthe blood substantially dampens the resonant vibrations. Thus, ourintent is to avoid unacceptable resonant vibration amplitudes, and theeasiest way to do this is to avoid resonant peaks completely. However,the scope of our invention includes resonating implants wherein theresonant amplitudes are safely below damage thresholds but above thosethat aid in deposit indirect-attack. Thus, specifically included withinthe ambit of the invention is the avoidance of known or measured(in-vivo or ex-vivo) resonant frequencies or the use of such resonantfrequencies in a manner not exciting damaging resonant amplitudes in thepresence of the existing damping. Thus, the acoustic energy may be oneof (a) does not appreciably resonate the implant, member or organ at oneof its resonant frequencies that could otherwise cause damage to theimplant, member or organ, or (b) does appreciably resonate the implant,member or organ at a resonant frequency thereof, but does so at anamplitude below that known to damage the implant, member or organ andthe resonance is not employed for indirect deposit-attack, or (c) doesappreciably resonate the implant, member or organ but does so below animplant damage threshold but above a deposition-attack threshold.

[0065] The optional use of drugs is mentioned above. A variety of drugsmay be used, including, but not limited to, thrombolytic therapy drugs(clot dissolvers), including drugs such as alteplase (Activase®),anistreplase (Eminase®), streptokinase (Streptase® or Kabikinase®),urokinase (Abbokinase®), and tissue plasminogen activators referred toas TPAs of various sorts (types of TPA), or an anti-clotting,anti-coagulant or anti-platelet drug such as a clotting factorinhibiting drug include warfarin (Coumadin®), a thrombin inhibitor suchas heparin or lepirudin (Refludan®) or an anti-platelet drug such asaspirin, ticlopidine (Ticlid®), clopidogrel (Plavix®), tirofiban(Aggrastat®) and eptifibatide (Integrilin®). The drugs may be employedbefore, during or after an acoustic exposure in order to aid in removalor erosion of the deposits. The acoustic energy may accelerate or enableaction of the drug. The drug(s) may be locally delivered to thedeposits, such as via a catheter or working port of a scope or may besystemically delivered.

[0066] Alternatively, the ultrasound may act alone without thrombolyticdrugs or any other drugs which directly or indirectly assist in depositremoval. One may also choose to administer a drug in association withthe inventive acoustic treatments simply to prevent any potentialside-effects of the acoustic exposures themselves.

[0067] One may characterize an artificial implant before or soon afterimplantation to understand its acoustic signature in its cleandeposition-free condition. This scheme is particularly useful forcharacterizing leaflet deposits on prosthetic valves because theoccluders are mainly liquid-loaded and have only small acoustic lossesout their hinges 3E, 3F. Thus, deposits on the leaflets or hinges willnoticeably affect the spectral fingerprint of such a valve. The worstdeposits, those that mechanically interfere with the leaflet or occludermotion or occluder seating, will have the largest acoustic fingerprintchange. By “fingerprint” is meant an acoustic signature that has one orboth of the following content: (a) a passively received spectracomprising naturally generated noises coming from the valve or thevalve's functioning and (b) actively generated spectra generated usingacoustic excitations. Particularly with regard to (a), it is widely knowthat heart valves can be quite audibly (and inaudibly) noisy and caneven be heard by the patient on occasion; thus, efforts go intodesigning them to be as quiet as possible. So within the scope of theinvention is the taking of acoustic fingerprints of such implants,preferably before and after depositions, using sensitivereception-microphones or transducers, such that the acoustic effects ofsuch depositions can be used to deduce fouling or deduce the progress offouling removal. Those who have used ultrasound imaging realize that itis not always possible to image such deposits until they are quitelarge. Thus, this additional fingerprinting tool is provided hereinwhich is more sensitive to small depositions, particularly on movingparts. Use of this fingerprint tool does not preclude ultrasound imagingand may even be incorporated into an ultrasound imaging transducer.Consequently, the acoustic emitter may also comprise or be co-mounted,co-packaged or used in association with an acoustic device used togather an acoustic fingerprint indicative of the extent, location ornature of deposits. Alternatively, the fingerprints may be taken orgenerated by an acoustic device that is independent of the acousticemitter.

[0068] It should also be emphasized that an implant portion, such as aleaflet 3A, 3B, can be driven not only at a resonant frequency but canalso be driven directly or indirectly at one of its higher harmonicfrequencies. Specifically included within the scope of the invention areacoustic illuminations for finger-printing that excite harmonicsdirectly (by driving at the harmonic frequency) or indirectly (bydriving at the primary frequency) or by driving in a broadband manner.Driving at a resonance or harmonic will maximize the signal to noiseratio, but one must remain below pre-known and pre-characterizedcritical amplitudes that could cause breakage.

[0069] Returning to the description of the invention, it was mentionedthat the cleaning of natural (pre-existing non-implanted) valves or ofnatural tissue overgrowths (pannus) onto artificial valves is includedwithin the teachings herein. A first example of this would be thecleaning of calcium deposits from a bioprosthetic (tissue-based) valvein a child. Such tissue-based replacement valves in children areparticularly prone to calcium deposits.

[0070] A second example would be the cleaning or necrosing of pannus,which is the lateral overgrowth of the patient's tissues into or onto anartificial prosthetic valve. In this unique case, killing living tissueoccurs and this procedure would tend to use the higher specified powersat the higher specified frequencies using a close-in delivery transducersuch as 7. This is because it is desired to preferably heat the pannusand kill it. In this example, the acoustic energy has a frequency withina range of 3 to 10 MHz and an acoustic power of several hundred to a fewthousand wafts/cm² at the most intense portion of the beam. Althoughthermal heating may be used to kill pannus, pannus may alternatively bekilled by cavitation or a combination of thermal heating and cavitation.

[0071] In general, deposits 11A, 11B, 11C will be formed of blood-basedthrombus and will be thermally blood-coupled. The point is that a fairamount of acoustic power may be delivered (tens or hundreds ofwafts/cm²) without appreciably heating the deposits because of theexcellent heatsinking situation to the blood and to the underlyingimplant itself. Obviously, if the underlying implant material is athermally conductive metal, this is particularly true. This will inviteeasier acoustic breakdown of the deposit without burning it into aninsoluble form. The same benefit extends to calcium deposits whetherthey be on or within artificial valves, bioprosthetic valves, naturalvalves or valve tissues. It is also noted that the implant in generalwill have an acoustic impedance that significantly mismatches that ofblood, such that energy delivery into the implant material itself isreduced in favor of delivery into the deposits in the known mannertaking account of the therefore-different acoustic reflectivities.

[0072] It is expected that it may be preferable to gate the energydelivery in time with the open or closed state of a moving functioningvalve. This would be for at least one of three reasons. The first isthat it may be easier to illuminate a leaflet-deposit at a particularangle of a moving leaflet. The second reason is that it may bebeneficial to use a portion of the implant or moving leaflet to shieldsome other portion of the heart (or implant) from the acoustics. Thethird reason is that it may be beneficial to allow cooling or allow formicroscopic debris to be carried off with each heartbeat, where thedebris is of sufficiently fine size that it can be allowed to pass intothe circulatory system safely. Finally, it may also be beneficial tointersperse imaging activity such as ultrasound B-mode or color flowmode imaging. It may also be beneficial to intersperse the previouslymentioned acoustic fingerprinting activity to assess deposition removalin real time.

[0073] Known to the ultrasonic arts of imaging and tissue therapy arenumerous RF-driving means and control-logic to excite such transducerswith single pulses, pulse trains, or continuous pulses. Also widelyknown are acoustic spectroscopic methods of taking acoustic fingerprintsof acoustic sounds and comparison methods to detect changes in suchfingerprints-such as by spectral subtraction. It is noted that a widevariety of such means would be useful to the practice of the presentinvention.

[0074] The three following additional special cases are also includedwithin the scope of the present invention:

[0075] 1. One may choose to permanently mount a therapy transduceradjacent to, upon, or physically within the implant (not shown). Forexample, the valve body 2 or leaflets 3A, 3B of the Figure could includean embedded or co-laminated miniature ultrasound transducer(s) thatexcites some or all of the valve structures or at least their surfacedeposits. This may be particularly doable if the transducing material isembedded and unexposed. Leads for electrical excitation of such aminiature transducer could be provided as necessary, as is known to thepacemaker art, for example.

[0076] 2. A functioning valve (or non-functioning stuck valve) may beheld in place for a few heartbeats or more in order to access depositswhich are otherwise hard to get to with a sufficient acoustic exposure.An exemplary case would be that wherein transducer 7 of the Figure iscovered by a saline-filled balloon (not shown) and the balloon is pushedinto or placed into the valve to hold it open in a damage-free mannerwhile it is inspected, fingerprinted and/or treated for deposit removal.The transducer would deliver its acoustics through the saline from astandoff distance, for example. One could also envelop the transducer ina balloon and insert the balloon/transducer into the valve if notthrough it to operate on the inside and/or far side of the valve.

[0077] 3. The transducer or acoustic emitter of the invention maycomprise a magnetostrictive transducer of the type widely known to theart. A key advantage of such transducers is that the excitation fieldthat excites the magnetostrictive material may optionally be remote fromthe excited material (the emitting implant component to be cleaned forexample). Thus, one could have a magnetic or electromagnetic varyingfield applied to the body non-invasively, yet still have the implantedprosthetic be excited acoustically via this magnetostrictive mechanism.This could thus be done without any tissue-penetrating leads.

[0078] It is emphasized that in the Figure, catheter item 7 is shown asbeing a forward-firing or emitting transducer. One may also utilize aside-firing transducer or radial-firing transducer, particularly if itis to be passed into the valve body as just mentioned, for example. Forthe purposes of the invention, an emitter emits acoustics regardless ofwhether the acoustics are themselves generated by the emitter, as theywould be for a transducer-emitter, but as they would not be if theemitter were simply an output port of an acoustic waveguide connected toa remote transducer pumping acoustics into the connecting waveguide. By“acoustic emissions” we mean at least one of compression, rare-factionor shear waves which travel at or near a speed of sound of a material.These may be single-pulse, multipulse, pulse-trains, bipolar pulses,unipolar pulses, symmetric pulses, asymmetric pulses, inaudiblevibrations or audible vibrations. They may have amplitudes in thegeneral range of a micron or so up to a fraction of a centimeter per therecommended frequency limits. The highest frequencies described have thesmallest wavelengths. Variable frequencies and therefore variablewavelengths may be employed as is known for broadband or multitoneemitters. These are a good choice to help avoid exciting a resonancethat is within the scanned frequency range.

[0079] Along the lines of item 2 above, included within the scope of theinvention are transducers or emitters that are mounted in or held bysurgical tools, clamps, balloons or other manipulators that aid thesurgeon. Such manipulators may, for example, include all manner ofaccess scopes, laparoscopes, gastroscopes, catheters, cannulas, handheldtools, mechanical clamps, suction-based clamps or robotic grippers.Balloons or any other soft standoff or appendage may be interspersedbetween the emitter 7 and any portion of the implant, member or organand pass emissions to or from the implant, member or organ in a mannerto avoid damage or scratching the implant, member or organ. The balloon,standoff or appendage may be utilized to aid in the temporary clampingor holding of the moving part of the implant, member or organ such thatat least one deposit can be better accessed.

[0080] It will be clear to the reader now that one might furtherincorporate additional features along with the transducer(s) or acousticemitters. One such feature could be a suction or flushing means or atrapping means to either suck out removed debris or to catch it in afilter or net at, near or away from the implant being cleaned, eitherduring therapy and/or after the therapy. Such trash-collection featuresare known for clot-busters used in lumens and for carotid artery andcardiac installation. Another feature could be a modification to theimplant's geometry or to its material makeup to make it easier todeliver the inventive therapy or make it easier for the acoustics topass into certain regions of the targeted implant. For example, onemight provide a mating feature on the implant such that a portion of thetherapy emitter aligns favorably to illuminate or excite pre-selectedportions of the implant prone to deposition. As another example,silicone or other polymer might be used to at least coat portions of theimplant such that emitted acoustics are favorably absorbed causing atleast one of localized heating and localized flexure of the surfacessupporting the deposits. It should be noted that direct and indirectresonation can provide very appreciable surface deformations to aflexible silicone coating (or component) that can knock off or sheddeposits. One might also release the taught drugs locally at the implantas through a catheter. The present inventors stress that although thediscussion herein has focused on heart valves as an exemplary example,also included in the scope of the invention are lumen-based natural andartificial valves, such as those found in the venous systems of thelegs. Other candidate implants would include ports or other accessdevices wherein the moving part is yet another device, lead or catheterwhich must be passed into or through the port or access device on atleast one occasion or at least once after a deposit may have formed.What all of these have in common is that deposits may interfere with amechanical operation or function necessary for the implant to serve itsfunction.

[0081] The foregoing discussion has been primarily directed to theremoval of deposits around or upon moving parts of valves or implants.Other types of deposits known to cause valve problems are blood-bornebacteria, or even fungus, which frequently take up residence at or innatural or prosthetic valves. Such bacteria may get into the blood froma simple skin cut or from a dental procedure for example. Untreated,these bacteria can destroy the valve or at least cause blood-leakage atthe edges of the valve. Prosthetic valves and compromised natural valvesare particularly prone to such infectious damage. This valve infectionis called endocarditis. The blood leakage is endocarditis-causedleakage. Included within the scope of the invention is the acoustictreatment of endocarditis tissues in or around natural or prostheticheart valves. This treatment of infection or leakage-damage caused bydeposited bacteria may comprise one of two types. The first type isoutright killing of the bacteria by acoustic energy exposure or by theheat generated by such an exposure. The acoustic emissions may bedirected, at least in part, to a prosthetic valve component, wherebyacoustic heating of the component causes heat to be conducted intoadjacent endocarditis-laden tissue, thereby at least partially killingthe endocarditis bacterial or fungus. A catheter or otherlumen-delivered device may, for example, be used to deliver the acousticemissions.

[0082] The second type is sealing of blood leakage at thebacteria-caused leaks, such as by heat-induced blood clotting to plugsuch leaks. Such acoustic emissions may serve as a therapy forendocarditis. In all cases, the bacterial deposit is attacked and atleast partly killed and thus is in keeping with the teaching herein ofremoving or reducing undesired depositions. Consistent with the otherteachings herein, one may utilize an antibacterial or other helpful drugwith the ultrasound exposure delivered to the valve or implant in anymanner. Such a drug might be delivered locally to the infected valve viathe aforementioned optional inflated balloon covering the emitter. Thepreviously mentioned ranges or acoustic power and frequency are alsoapplicable-particularly the higher powers and frequencies.

[0083] The therapy treatment may require only one therapy session.Alternatively, two or more therapy sessions may be conducted atdifferent times or on different days.

[0084] The reader will readily appreciate that the inventive therapeuticacoustic emitters and/or fingerprinting apparatus can optionally becointegrated with an ultrasonic imaging probe such that two or more ofvisualization, fingerprinting, and therapy can be delivered by one tool.

What is claimed is:
 1. Apparatus capable of the non-contact ordamage-free removal, breakdown or erosion of undesirable depositssituated: (a) on or in an implanted artificial or bioprosthetic devicehaving at least one moving or movable part or portion, or (b) on or in anatural bodily member or organ having a naturally moving part orportion, the deposits interfering or potentially interfering with atleast one of (a) any designed function or maintenance of said implanteddevice, (b) any natural function of said natural bodily member or organor (c) any circulatory system process necessary for normal healthyliving, said apparatus comprising: an acoustic emitter capable ofemitting acoustic energy; a means for exciting said acoustic emitter toemit acoustic energy; a means for acoustically coupling said acousticenergy into said deposits directly or indirectly; a means for operatingsaid emitter(s) to at least partially remove, break-down or otherwiseerode said deposits; and optionally, an administered drug to aid saidremoval or erosion process, to prevent or slow further such deposits, orto treat a side-effect of treatment with said acoustic emitter.
 2. Theapparatus of claim 1 wherein said at least one moving part is anoccluder or leaflet in a natural, artificial or bioprosthetic valveanywhere in the body.
 3. The apparatus of claim 2 wherein said occluder,at least in part, is made of a biocompatible engineering material. 4.The apparatus of claim 2 wherein said occluder, at least in part, ismade of a tissue material of any type, natural or bioprosthetic.
 5. Theapparatus of claim 4 wherein said tissue is, at least in part, donorhuman tissue, donor animal tissue, or lab-grown tissue.
 6. The apparatusof claim 2 wherein said occluder is a portion of a patient's own naturalvalve, anywhere in the body.
 7. The apparatus of claim 6 wherein saidnatural valve is a cardiac valve or a venous valve or a lymphatic valve.8. The apparatus of claim 1 wherein said deposits are on or in at leastone of the moving or nonmoving parts of said implant, member or organ.9. The apparatus of claim 1 wherein at least some of said depositsinterfere with the proper moving of a moving part of said implant,member or organ or interfere with a moving part or medical devicearranged or designed to be passed through, passed into, mated to orthreaded into said implant, member or organ.
 10. The apparatus of claim1 wherein the presence of said deposits eases or encourages theformation of additional deposits.
 11. The apparatus of claim 1 whereinsaid deposits interfere with normal blood flow trajectories, normalhemodynamics or normal cardiac capacity.
 12. The apparatus of claim 1wherein said emitter is acoustically coupled into said deposits directlyusing at least one of a noninvasive, minimally invasive or invasiveapproach.
 13. The apparatus of claim 1 wherein said non-contactdeposition removal and lack of scratching or other damage to any portionof said implant, member or organ is provided by at least one of: (a) noportion of the emitter means contacts the implant, member or organ, (b)any portion of the emitter means that does contact the implant, memberor organ is chosen to be a compliant or deformable material.
 14. Theapparatus of claim 1 wherein at least one implant, organ or membermoving part or portion is at least temporarily immobilized by anyplacement of the emitter or any aspect of the therapy
 15. The apparatusof claim 14 wherein the immobilization is provided by the juxtapositionor insertion of a soft or compliant member that mechanically blocks saidmotion.
 16. The apparatus of claim 15 wherein the soft or compliantmember is an inflatable balloon or other pressurized member.
 17. Theapparatus of claim 16 wherein said inflation is by at least one of aliquid or a gas.
 18. The apparatus of claim 1 wherein said deposits atleast in part, comprise one of (a) blood constituents, clotted or not,(b) calcium-containing materials, (c) fatty deposits, (d) bodily organicdebris, (e) pannus, and (f) bacteria or bacterial infected matter. 19.The apparatus of claim 18 wherein said deposits includeendocarditis-causing bacteria or fungus, said deposits occurring in,around or in infectious association with a natural or prosthetic valveor implant.
 20. The apparatus of claim 19 wherein said acousticemissions result in at least one of (a) directly destroying saiddeposits, (b) thermally destroying said deposits, (c) plugging ablood-leak caused by such deposits, (d) plugging a blood-leak andsimultaneously killing at least some of said deposits, and (e) servingas a therapy for endocarditis.
 21. The apparatus of claim 20 whereinacoustic emissions are directed at at least some said depositssurrounding a natural or prosthetic valve and said deposits are at leastpartly killed by at least one of direct acoustic radiation or heatgenerated by acoustic radiation.
 22. The apparatus of claim 20 whereinacoustic emissions are directed, at least in part, to a prosthetic valvecomponent whereby acoustic heating of said component causes heat to beconducted into adjacent endocarditis-laden tissue, said endocarditisbacteria or fungus being at least in part killed by said conductedthermal energy.
 23. The apparatus of claim 20 wherein a drug actingagainst endocarditis is locally or systemically delivered to said valveor implant in any manner.
 24. The apparatus of claim 23 wherein saidlocalized delivery is by delivery of the drug from an inflatableballoon.
 25. The apparatus of claim 20 wherein said acoustic emissionsare delivered to the valve or implant from a catheter or otherlumen-delivered device.
 26. The apparatus of claim 1 wherein said drugis employed at least one of before, during or after an acoustic exposurein order to aid in removal, breakdown or erosion of said deposits or toameliorate a side-effect of the acoustic therapy.
 27. The apparatus ofclaim 26 wherein said acoustic energy accelerates or enables anyfavorable action of said drug.
 28. The apparatus of claim 1 wherein saidacoustic energy has a frequency with a wavelength on the order of acharacteristic dimension of said deposits or of a deposit constituent inorder to enhance acoustic coupling to the deposit or depositconstituent.
 29. The apparatus of claim 1 wherein said acoustic energyhas a frequency with a wavelength which purposely excites a resonance orresonance harmonic in a portion of the implanted device or purposelyavoids such a resonance.
 30. The apparatus of claim 29 wherein saidresonant excitation contributes to indirect delivery of acoustic energyinto said deposits and said indirectly-delivered energy contributes toremoval, break-down or erosion of said deposits.
 31. The apparatus ofclaim 1 wherein said acoustic energy causes at least one of bloodstreaming, cavitation, erosion, break-down or dissolution in the regionof said deposits.
 32. The apparatus of claim 31 wherein said streamingor cavitation aids the removal, break-down or erosion of at least aportion of said deposits.
 33. The apparatus of claim 1 wherein saidacoustic energy aids in the permeation of said deposits by at least oneof a drug or a blood constituent.
 34. The apparatus of claim 1 whereinthe removal of said deposits prevents a potential stroke or any cardiacdysfunction or degraded function.
 35. The apparatus of claim 1 whereinsaid drug is selected from the group consisting of (1) thrombolytictherapy or clot-dissolving drugs, (2) tissue plasminogen activators or atype thereof, (3) anti-clotting, anti-coagulant or anti-platelet drugs,and (4) thrombin inhibitor or anti-platelet drugs.
 36. The apparatus ofclaim 35 wherein said drug is selected from the group consisting ofalteplase, anistreplase, streptokinase, urokinase, warfarin, heparin,lepirudin, aspirin, ticlopidine, clopidogrel, tirofiban, andeptifibatide.
 37. The apparatus of claim 35 wherein said drug isutilized at least one of before, during or after said treatment.
 38. Theapparatus of claim 1 wherein two or more therapy sessions are conductedat different times or on different days.
 39. The apparatus of claim 1wherein said implant includes a valve or occluder of any type supportiveof a patient's cardiac, lymphatic or arterial systems.
 40. The apparatusof claim 39 wherein said implant includes at least one biocompatibleengineering material in its construction.
 41. The apparatus of claim 39wherein said implant includes at least one artificial or donor-tissuematerial in its construction.
 42. The apparatus of claim 1 wherein aballoon or other soft standoff or appendage is interspersed between saidemitter and any portion of said implant, member or organ and passesemissions to or from said implant, member or organ in a manner avoidingdamage or scratching of said implant, member or organ.
 43. The apparatusof claim 1 wherein a balloon, standoff or appendage is utilized to aidin the temporary clamping or holding of said moving part of saidimplant, member or organ such that at least one deposit can be betteraccessed, inspected or treated.
 44. The apparatus of claim 43 whereinsaid moving part of said implant, member or organ is an occluder. 45.The apparatus of claim 1 wherein said direct energy deposition upon orinto said deposits involves said emissions passing through at least oneblood, liquid or tissue path between said emitter and said deposits. 46.The apparatus of claim 1 wherein said indirect energy deposition upon orinto said deposits involves said acoustic emissions first coupling intosaid implant, member or organ and then said acoustic energy in turnbeing delivered to a deposit from the implant, member or organ it isresident upon or within.
 47. The apparatus of claim 1 wherein saidacoustic energy at least one of (a) does not appreciably resonate saidimplant, member or organ at one of its resonant frequencies that couldotherwise cause damage thereto or (b) does appreciably resonate saidimplant, member or organ at an implant resonant frequency but does so atan amplitude level below that known to damage said implant, member ororgan.
 48. The apparatus of claim 1 wherein said deposits' interferencewith the designed or natural function of said implant, member or organcomprises interference in the desired hydrodynamic operation of anatural or implanted valve supporting the heart, the lymphatic system orthe arterial system.
 49. The apparatus of claim 48 wherein said depositsare on a seat or sealing edge or face of said valve, in a hinge, pivotor flexural area of said valve, or on an occluder component or leafletof said valve.
 50. The apparatus of claim 1 wherein said depositsinclude pannus growth and said acoustic energy is used to either stopsaid pannus growth or remove said pannus growth by cavitation, heatingor thermal necrosis.
 51. The apparatus of claim 1 wherein said acousticemitter is at least temporarily integrated either into the patient'sbody or into said implant itself.
 52. The apparatus of claim 51 whereinsaid acoustic emitter can be automatically operated without constantpatient or doctor manipulation.
 53. The apparatus of claim 1 whereinsaid acoustic emitter is one of a piezoelectric, ferroelectric,electrostrictive, magnetostrictive, optoacoustic or thermoacousticemitter.
 54. The apparatus of claim 1 wherein said acoustic emitter isintegrated or co-mounted with an imaging device selected from the groupconsisting of an ultrasound transducer, an infrared camera or an imagingscope of any type.
 55. The apparatus of claim 1 wherein an independentimaging device is employed to guide or plan said treatment.
 56. Theapparatus of claim 55 wherein the independent imaging device is one of(a) ultrasound imaging, (b) fluoroscopy, (c) MRI, (d) CAT scan, (e) PET,or (f) videoscope with a waterpath.
 57. The apparatus of claim 1 whereinsaid drug is locally delivered to said deposits in any manner.
 58. Theapparatus of claim 57 wherein said local delivery is via a catheter orworking port of a scope.
 59. The apparatus of claim 1 wherein saidacoustic energy is coupled into said implant, member or organ by (a)coupling to a patient's external skin, (b) coupling from within apatient's natural body passage or space, (c) coupling into the surfaceof a surgically exposed or accessed organ or tissue surface, (d)coupling from a lumen as by a catheter, or (e) coupling from within acardiac chamber or flowpath.
 60. The apparatus of claim 1 wherein saidacoustic emitter also comprises or is co-mounted, co-packaged or used inassociation with an acoustic device used to gather an acousticfingerprint indicative of the extent, location or nature of deposits.61. The apparatus of claim 1 wherein one or more acoustic fingerprintsare taken or generated by an at least second acoustic device independentof said acoustic emitter, the acoustic fingerprint or fingerprints beingindicative of the extent, location or nature of deposits.
 62. Theapparatus of claim 1 wherein a suction device, catching filter or othertrapping means is used to collect or at least immobilize debris removedfrom said implant during said treatment or by said treatment.
 63. Theapparatus of claim 1 wherein debris generated by said treatment isarranged to be of sufficiently fine size that it can be allowed to passinto the circulatory system safely.
 64. The apparatus of claim 1 whereinsaid deposits comprise at least one of (a) surface-deposited,calcium-containing material, (b) calcium-based deposits inside tissuesor in tissue interfaces, (c) calcium-based deposits inside implantmaterials or in an interface including at least one implant material,(d) fatty deposits on surfaces or inside tissues or engineeringmaterials, (e) organic debris on surfaces or inside tissues orengineering materials, (f) plaque-like deposits, and (g) any depositwhich contributes to stenosis or a loss of elasticity of a moving ormovable tissue or implant component.
 65. The apparatus of claim 1wherein said acoustic energy is within a range of 1 Hz to 100 MHz. 66.The apparatus of claim 65 wherein said acoustic energy is within a rangeof 1 KHz to 10 MHz.
 67. The apparatus of claim 66 wherein said acousticenergy is within a range of 5 KHz to 10 MHz.
 68. The apparatus of claim65 wherein said acoustic energy is chosen to either: (a) not excite aknown resonance of said implant, or (b) to excite a known resonance ofsaid implant below an amplitude that would damage the implant.
 69. Theapparatus of claim 65 wherein any parameter of said acoustic energy ischosen for its ability to remove said deposits upon direct radiation bysaid acoustic energy.
 70. The apparatus of claim 1 wherein said acousticenergy has an acoustic power within a range of milliwatts/cm² tokilowatts/cm².
 71. The apparatus of claim 70 wherein said power iswithin a range of 0.5 to 5,000 watts/cm².
 72. The apparatus of claim 71wherein said power is within a range of 5 to 500 watts/cm².
 73. Theapparatus of claim 1 wherein said acoustic energy is delivered by atleast one of a focused, unfocused or collimated beam transducer and saidacoustic emitter is at least one of mechanically focused orelectronically focused.
 74. The apparatus of claim 1 wherein saiddeposits comprise pannus.
 75. The apparatus of claim 74 wherein saidacoustic energy has a frequency within a range of 3 to 10 MHz and anacoustic power of several hundred to a few thousand watts/cm² at themost intense portion of the beam.
 76. The apparatus of claim 74 whereinsaid acoustic energy causes said pannus to be killed via thermal heatingand/or cavitation.
 77. The apparatus of claim 1 wherein said acousticenergy causes beneficial cavitation, said cavitation optionally beingaided by the presence of cavitation nuclei or facilitators.
 78. Theapparatus of claim 77 wherein said cavitation nuclei or facilitators areselected from the group consisting of contrast microbubbles, gasbubbles, and surfactants.
 79. The apparatus of claim 1 wherein thedeposits are present in or on a body organ undergoing perfusive motion,the perfusive motion being interfered with directly or indirectly, atleast locally, by the deposits.
 80. The apparatus of claim 79 whereinthe member is any one of a heart, kidney, liver, muscle or tendon. 81.The apparatus of claim 1 wherein the deposits are present in, on or nearan implant and they potentially interfere with maintenance, repair orremoval of any portion of the implant.
 82. The apparatus of claim 81wherein the movable member comprises the desired moving of an implantportion to be maintained, serviced, replaced or removed.
 83. Theapparatus of claim 1 wherein the emitter therapy allows for a reductionin the use of any anti-deposit drug or avoidance of use of anyanti-deposit drug which would have been otherwise used, at any point, ifnot for the availability of the emitter therapy.
 84. The apparatus ofclaim 1 wherein the member is a temporary implant such as a drain orport, the drain or port requiring unimpeded passage through it and beingsubject to blockage, fouling or plugging by a deposited material whichdesires to be avoided.
 85. An acoustic method capable of the non-contactremoval, break-down or erosion of undesirable deposits on or in animplant comprising an implanted artificial or bioprosthetic devicehaving at least one moving or movable part or portion, the depositsinterfering or potentially interfering with at least one of (a) thedesigned proper functioning or maintenance of said implant or (b) anatural circulatory system process necessary for normal living, saidmethod comprising: providing an acoustic emitter capable of emittingacoustic energy; exciting said acoustic emitter to emit said acousticenergy; acoustically coupling said acoustic energy into said deposits,directly or indirectly, to at least partially remove, break-down orotherwise erode said deposits; either passing said at least partiallyremoved deposits or otherwise broken-down or eroded deposits into thebody or physically removing said at least partially removed deposits orotherwise eroded or broken-down deposits by a collection or trappingmeans; and optionally administering a drug to aid said removal, saiddeposits thereby being at least partially removed from said implant. 86.A method of assessing the state of fouling by undesirable deposits of animplant or of a natural valve in a living body, the implant or valvehaving at least one moving or movable part, said method comprising:obtaining, in any manner, an acoustic signature of the operation of saidimplant or valve or valve-model at least under unfouled conditionsinside or outside a living body; obtaining, in any manner, using passivereception or pulse-echo active probing, an acoustic signature of saidimplant or valve thought to possibly have fouling thereon or therein;the possibly-fouled signature containing at least one of: (1) naturallygenerated acoustic features known to be caused by fouling, and (2)artificially excited features known to be excited upon the presence offouling; comparing the fingerprints looking for fouling features thathave newly been incorporated into the signature; and concluding thatnewly added features which match known fouling features indicatefouling.
 87. The method of claim 86 wherein said acoustic signaturefouling feature relates to acoustics generated by a fouling deposit ormodifications to the normal unfouled acoustics expected of an unfouledmoving or movable implant part or of blood moving therein or thereby.88. The method of claim 86 wherein said implant or valve is imaged andsaid acoustic signature is synchronized with the motion of said implantor valve.